Effects of Vitamin D and Fish Oil on the Kidney in Hypertensives
NCT ID: NCT02757872
Last Updated: 2024-05-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
2232 participants
INTERVENTIONAL
2016-04-30
2022-03-31
Brief Summary
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Detailed Description
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Vitamin D and omega-3 fatty acids are promising interventions for kidney disease prevention and treatment, based on results of animal-experimental models and early human studies. Because these interventions are relatively safe, inexpensive, and widely available, they may offer opportunity to substantially reduce the burden of kidney disease in large populations. This VITAL ancillary study will test whether vitamin D3 and/or omega-3 fatty acids prevent loss of glomerular filtration rate, over 4 years of therapy.
In VITAL, 25,875 participants have been randomly assigned in a 2x2 factorial design to vitamin D3 (cholecalciferol) 2000 IU daily versus placebo, and to eicosapentaenoic acid 465 mg plus docosahexaenoic acid 375 mg daily versus placebo, and followed for a mean of 5 years to assess effects on cardiovascular disease and cancer events. This ancillary study will identify and recruit a sub-cohort of VITAL participants with hypertension at baseline and ascertain effects of study interventions on glomerular filtration rate in this group. Blood samples will be collected at year 4 simultaneously for measurement of estimated glomerular filtration rate (using serum creatinine and cystatin C) and other relevant biomarkers. This VITAL ancillary study is designed to determine whether vitamin D3 and/or omega-3 fatty acids have causal and clinically relevant effects on the development and progression of kidney disease in hypertensives.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
TRIPLE
Study Groups
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Vitamin D and Omega-3 Fatty acids
Dietary Supplement: Vitamin D Vitamin D3 (cholecalciferol), one 2000 IU capsule per day.
Drug: Omega-3 fatty acids (fish oil) Omacor, 1 capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid \[EPA\] and 375 mg of docosahexaenoic acid \[DHA\]).
Vitamin D3
Vitamin D3 (cholecalciferol), 2000 IU per day
Omega-3 Fatty acids
Omacor, 1 capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid \[EPA\] and 375 mg of docosahexaenoic acid \[DHA\])
Vitamin D and Omega-3 Fatty acid Placebo
Dietary Supplement: Vitamin D Vitamin D3 (cholecalciferol), one 2000 IU capsule per day.
Dietary Supplement: Omega-3 fatty acid placebo (Fish oil placebo)
Vitamin D3
Vitamin D3 (cholecalciferol), 2000 IU per day
Fish oil placebo
Fish oil placebo
Vitamin D Placebo and Omega-3 Fatty acids
Drug: Omega-3 fatty acids (fish oil) Omacor, 1 capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid \[EPA\] and 375 mg of docosahexaenoic acid \[DHA\]).
Dietary Supplement: Vitamin D placebo. One capsule per day Vitamin D3 placebo
Omega-3 Fatty acids
Omacor, 1 capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid \[EPA\] and 375 mg of docosahexaenoic acid \[DHA\])
Vitamin D3 placebo
Vitamin D3 placebo
Vitamin D Placebo and Omega-3 Fatty acid Placebo
Dietary Supplement: Vitamin D placebo. One capsule per day Vitamin D3 placebo
Dietary Supplement: Omega-3 Fatty acid Placebo (Fish oil placebo). One capsule per day
Vitamin D3 placebo
Vitamin D3 placebo
Fish oil placebo
Fish oil placebo
Interventions
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Vitamin D3
Vitamin D3 (cholecalciferol), 2000 IU per day
Omega-3 Fatty acids
Omacor, 1 capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid \[EPA\] and 375 mg of docosahexaenoic acid \[DHA\])
Vitamin D3 placebo
Vitamin D3 placebo
Fish oil placebo
Fish oil placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
50 Years
99 Years
ALL
No
Sponsors
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Brigham and Women's Hospital
OTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Albert Einstein College of Medicine
OTHER
Responsible Party
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Principal Investigators
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Michal L Melamed, MD, MHS
Role: PRINCIPAL_INVESTIGATOR
Albert Einstein College of Medicine
Locations
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Brigham and Women's Hospital
Boston, Massachusetts, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Other Identifiers
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2014-3778
Identifier Type: -
Identifier Source: org_study_id
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